Drugmaker Purdue Pharma and its owners, the Sackler family, have for years borne the brunt of public criticism for inventing and deceptively marketing one of the most well-known opioid painkillers, OxyContin, in the 1990s. But the records show that by 2006, as the death rate accelerated, a handful of obscure generic-drug manufacturers were selling the bulk of opioid pills flooding the country.
The documents and a DEA database that tracks every opioid pill sold in the United States from 2006 through 2012 are being made public a year after The Washington Post and the owner of the Charleston Gazette-Mail in West Virginia began pushing for their release. The database provides a road map of accountability for these sales. It attributes the vast majority of the 76 billion opioid pills produced and shipped from 2006 through 2012 to three companies that are now controlled by large multinational drugmakers: SpecGx, a subsidiary of Ireland-based Mallinckrodt; Par Pharmaceutical, owned by Endo Pharmaceuticals, also in Ireland; and Actavis, part of Israel-based Teva Pharmaceutical Industries.
The records show how these and other generic-pain-pill makers rushed to gain market share as the nation’s deadliest drug epidemic spun out of control. The records also reveal that some of the manufacturers were warned by auditors or regulators that they were not meeting federal requirements for detecting suspicious orders.
On the DEA's radar By 2004, eight years after it had been introduced, OxyContin had mushroomed into the most frequently prescribed brand-name narcotic for moderate to severe pain in the United States. For Purdue, it had been an era of enormous profitability as the exclusive producer of the drug, which earned the company more than $1 billion a year.
But in several court rulings, federal judges in New York and Washington that year invalidated a Purdue patent on OxyContin for misrepresenting to regulators how effective the drug was at lower doses. The decisions helped clear the way for generics manufacturers to compete for market share years earlier than they might have otherwise. Although Purdue would ultimately prevail on appeal, the dam had broken; generics began pouring into the market.
Typically, generic-drug companies are able to produce less-expensive versions of a patented drug only long after its introduction, by which time its risks and benefits are well known. In the case of OxyContin, however, those risks were very much in dispute. In 2007, Purdue and several people who were then current and former executives pleaded guilty in federal court and agreed to pay a total of $635 million to settle charges they had fraudulently marketed OxyContin as a drug that was less addictive than other narcotics and that had few side effects.
Since the landmark fine for deceptive marketing, opioid manufacturers have faced few penalties. Mallinckrodt became the first in 2017, paying $35 million to settle DEA complaints it did not adequately work to detect suspicious opioid orders.
Three years before Purdue’s settlement, the Food and Drug Administration approved the first generic versions of OxyContin, known as oxycodone hydrochloride. Among the early drugmakers to win approval for a generic was Amide Pharmaceutical, a privately held company in Little Falls, N.J., with 200 employees.
With its approval in hand, and construction of a manufacturing plant underway to make billions of pills a year, Amide became the target of a buyout by what was then Actavis, a company based in Europe. Announcing the purchase in 2005, Actavis boasted that Amide would give the company an “important foothold in the US market .?.?. to generate significant opportunities to drive revenue growth.” Months later, Actavis bought a second New Jersey generics company and installed one of its executives, Boothe, as the head of the companies’ combined generics division.
Actavis’s sales of the generic version of OxyContin and other drugs containing oxycodone grew from 559 million in 2006 to more than 1.1 billion in 2012, according to the DEA database. Its sales of hydrocodone, another opioid pain reliever, rose from 2.2 billion to nearly 3 billion.
Even as their sales of opioids surged, the generic drugmakers maintained a low profile. “We weren’t really a household name — none of us,” Nancy Baran, Actavis’s head of customer service in those years, said in a recent interview. “Generics are not advertised on TV. No one ever hears your name. I worked at the company for 10 years, and my friends would still ask, ‘Where?’ ”
Inside the DEA’s headquarters near the Pentagon in Northern Virginia, however, Actavis and Mallinckrodt would eventually bubble up on the radar of agents frustrated with their inability to curb the steep increase in prescribed opioids. The DEA had tried going after unscrupulous doctors, but each case took months to stop a single bad actor. Agents had met with distributors, pressing them to cut off suspicious pharmacies, but the flow of drugs kept increasing. “We kept trying to work our way back up the chain, to the source,” Barbara J. Boockholdt, then the chief of the regulatory section for DEA’s Office of Diversion Control, said in an interview.
In 2011, Boockholdt walked across the hallway at DEA headquarters to an office that handles the agency’s drug-ordering database — known as the Automation of Reports and Consolidated Orders System, or ARCOS — and asked for reports on the nation’s largest opioid manufacturers.
“I was shocked; I couldn’t believe it, Mallinckrodt was the biggest, and then there was Actavis,” Boockholdt said. “Everyone had been talking about Purdue, but they weren’t even close.”
Agents in Boockholdt’s office analyzed the supply chains, tracing oxycodone from Actavis’s plants in New Jersey to Walgreens and other pharmacies in Florida, some selling a million doses a year. They put together a presentation that ran more than 100 pages, a document that was made public on Tuesday. They put copies in three-ring binders and called in Actavis.
On Sept. 12, 2012, executives from the company were led into a windowless conference room on the sixth floor of the DEA’s headquarters. There, one of Boockholdt’s deputies began by talking about how Florida was having, on average, 11 fatal overdoses a day.
Then the lights were dimmed, and Boockholdt ticked through 60 charts and graphs showing that Actavis had sent nearly 240 million pills to Florida during the previous 30 months — more oxycodone than the manufacturer had sent to almost all other states combined.
Actavis officials were taken aback, the court records show. Michael R. Clarke, the company’s vice president for ethics and compliance, testified in a deposition that it felt like DEA officials were treating Actavis like “street dealers.” Clarke had expected a more collegial approach like, “You know, that’s great, that’s fine, maybe you can do this better. We were looking for that sort of interchange, and it wasn’t that,” Clarke testified in December, according to the newly unsealed documents. “It was pretty clear that they believed that we were one of the manufacturers that led to whatever problem they identified related to diversion of opioids.”
Boockholdt told Baran, Actavis’s head of customer service, that she needed to send people to South Florida to get to know the company’s customers — “the long lines at pain clinics, out-of-state license plates, questionable clients, security guard (s) in the parking lots and signs stating cash payments only.”
